AccessGUDID - DEVICE: Model 4 CT Calibration Phantom (B052PHCTM40)

GUDID

Device Identifier (DI) Information

Brand Name: Model 4 CT Calibration Phantom
Version or Model: 4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MINDWAYS SOFTWARE, INC.

Primary DI Number: B052PHCTM40
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964202592 *Terms of Use

Device Description: Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40622	Bone densitometry x-ray phantom, test object	A device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of x-ray based bone density measurement systems and associated image acquisition, display, and analysis computer programs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGI	Densitometer, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002113	000
K030330	000
K140342	000
K894854	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a19b2f0d-df0b-4831-a2a2-f2fa65aa0741
Public Version Date: May 12, 2023
Public Version Number: 1
DI Record Publish Date: May 04, 2023